HIV/AIDSNCT05193942
Type 1 Hybrid Trial of Our Plan - a Brief, Couples-based HIV/STI Prevention Intervention
A study testing Intervention Our Plan in people with HIV/AIDS, run by Florida International University at 1 site in United States.
Trial summary
This webapp, couples-based HIV/STI prevention intervention project will use a Type 1 Hybrid Design Trial to determine efficacy to reduce HIV risk via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a new relationship (defined as 1 year or less). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Intervention Our Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-reported that currently self-identifies as a male
- self-reported in a sexual relationship with another self-identified male
- self-reported relationship length between 1 and 12 months
- self-reported anal sex with relationship partner in past month
- owns and uses an Internet-connected device (smartphone, tablet, computer)
- resides in the U.S.
- self-reported ability to read and understand English-language
Who cannot join
- Does not meet one or more of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
This webapp, couples-based HIV/STI prevention intervention project will use a Type 1 Hybrid Design Trial to determine efficacy to reduce HIV risk via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a new relationship (defined as 1 year or less). In addition, the project will be one of the first studies to investigate how intervention usage is associated with the outcomes over time, as well as explore best practices for future implementation and dissemination of such interventions by considering a variety of potential contexts. As such, the project is innovative, timely, and rigorous with sound scientific premise for helping to advance and bridge webapp HIV prevention science with existing community-level services.
Read the detailed description
The beginning of a relationship (i.e., within first year) is a crucial time for male couples to make decisions about their HIV/STI and sexual health needs. Via a recently completed nation-wide pilot RCT, the theoretically-grounded, couples-based app intervention showed high acceptability and feasibility, and strong promise for encouraging 42 male couples to create a tailored, prevention plan consisting of evidence-based strategies that aligned with the dyad's HIV serostatus. Retention was 86%, signifying that both partners of each couple completed all assessments, used the app intervention as designed, and participated in an individual-level exit interview. Acceptability was >95%, and confirmed by using three different data sources (quantitative follow-up assessment, paradata from app intervention use, qualitative interview). The app intervention contained 4 modules (M1-M4) and a geo-locator sexual health resource finder. Although relationship partners individually used the app intervention (on their respective smartphones), questions and activities were built in each module to highlight within-couple comparisons and also encouraged couples to participate in discussion activities together. M1 was about enhancing communication and decision-making skills, while M2 focused on prevention strategies including creating a tailored prevention plan. M3 highlighted statistics of the HIV/STI epidemic, and M4 was about stigma and discrimination. Regarding promise, a two-fold increase was observed in the proportion of couples who created a tailored prevention plan when comparing baseline to follow-up assessment data, and while also considering their paradata. The next steps in this line of work would aim to improve the app intervention by integrating some of the acceptability feedback received, such as offering it in English and Spanish and adding content about importance of ART/PrEP adherence. Next steps also include, investigating - via mixed methods - how best to integrate the app intervention with local AIDS-service organizations (ASOs) and Community-based organizations (CBOs) for future scale up and improve use and adherence of evidence-based strategies among sexual minority men. Last but not least, a 4-month, Type 1 Hybrid Trial will be conducted to establish efficacy on couples' creation of a prevention plan, as well as participants' uptake of new evidence-based strategies (e.g., daily PrEP, regular testing, daily ART) and improving adherence of strategies currently in use. Findings from the Type 1 Hybrid Trial would inform best practices for integrating mHealth intervention science with brick-and-mortar services by including perspectives from the target population and ASOs/CBOs. The Type 1 Hybrid Trial study would occur in locations identified in Ending the HIV Epidemic Plan, such as Miami-Dade and Broward Counties in Florida.
- Conditions
- HIV/AIDS
- Being tested
- Intervention Our Plan, Internation Informational Control
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Our PlanBehavioural
From day 1 to day 120 (i.e., entire 4 month duration) of the trial, participants randomized to the intervention arm will be granted access and instructed to use the Our Plan program as directed. The Our Plan program includes modules covering topics of communication, decision-making, HIV/STI prevention, and stigma and discrimination. Each module contains content, questions, and activities for the participant and couple to complete. One goal of OurPlan is to help both partners of the couple create and use a risk- reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own confidence, intention, and perceived ability to use these strategies.
Internation Informational ControlBehavioural
From day 1 to day 120 (i.e., entire 4 month duration) of the trial, participants randomized to the informational control condition will receive a webpage that contains information about HIV/STI prevention options and resources. This control condition represents the current equivalent of a standard of care for online HIV resources.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | From baseline to 4-month post-test, participants in the intervention arm will have access to the Our Plan web app program. Receives: Behavioral: Intervention Our Plan |
| Informational control | Other | From baseline to 4-month post-test, participants in the informational control arm will not have access to the Our Plan web app program. Participants will instead receive a webpage with information about HIV/STI prevention options and resources to represent the current equivalent of a standard of care for online HIV resources. Receives: Behavioral: Internation Informational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in creation of a detailed risk-reduction plan by comparing baseline response to month 4 response
At both time points, participants will be asked if they created a detailed risk-reduction plan that contains evidence-based strategies with their partner. Dichotomous measure: yes/no
Measured: Baseline, month 4
Change in number of evidence-based prevention strategies being used over time by comparing baseline response to month 4 response
Participants will be asked how many evidence-based HIV/STI prevention strategies they are currently using at both time points.
Measured: Baseline, month 4
Change in confidence about using evidence-based prevention strategies over time by comparing baseline response to month 4 response
Participants will be asked about their perceived confidence in using evidence-based HIV/STI prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type scale response range of 1-5.
Measured: Baseline, month 4
Change in intention to use evidence-based prevention strategies over time by comparing baseline response to month 4 response
Participants will be asked about their perceived intention to use evidence-based prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type scale response range of 1-5.
Measured: Baseline, month 4
Change in self-efficacy to use evidence-based prevention strategies over time by comparing baseline response to month 4 response
Participants will be asked about their perceived ability to use evidence-based prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type response range of 1-5.
Measured: Baseline, month 4
Secondary outcomes (2)
Change in goal congruence on sexual health by comparing baseline response to month 4 response
Participants will be asked about their goal congruence regarding sexual health and their relationship partner at both time points. Validated theoretical measure containing 5 items, each containing a Likert-type response range of 1-5.
Measured: Baseline, month 4
Change in mutual constructive communication by comparing baseline response to month 4 response
Participants will be asked about their mutual constructive communication patterns at both time points. Validated theoretical measure containing 3 items, each containing a Likert-type response range of 1-9.
Measured: Baseline, month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start17 Feb 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4-month randomized controlled trial with an informational control condition
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193942
- Sponsor's protocol ID
- 3U54MD012393-05S2
- Status last verified
- Sep 2024
- First submitted
- 17 Nov 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Hybrid Trial of Our Plan - a Brief, Couples-based HIV/STI Prevention Intervention
- ClinicalTrials.gov ID
- NCT05193942
- Acronym / sponsor ID
- 3U54MD012393-05S2
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This webapp, couples-based HIV/STI prevention intervention project will use a Type 1 Hybrid Design Trial to determine efficacy to reduce HIV risk via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a new relationship (defined as 1 year or less). In addition, the project will be one of the first studies to investigate how intervention usage is associated with the outcomes over time, as well as explore best practices for future implementation and dissemination of such interventions by considering a variety of potential contexts. As such, the project is innovative, timely, and rigorous with sound scientific premise for helping to advance and bridge webapp HIV prevention science with existing community-level services.
Detailed description
The beginning of a relationship (i.e., within first year) is a crucial time for male couples to make decisions about their HIV/STI and sexual health needs. Via a recently completed nation-wide pilot RCT, the theoretically-grounded, couples-based app intervention showed high acceptability and feasibility, and strong promise for encouraging 42 male couples to create a tailored, prevention plan consisting of evidence-based strategies that aligned with the dyad's HIV serostatus. Retention was 86%, signifying that both partners of each couple completed all assessments, used the app intervention as designed, and participated in an individual-level exit interview. Acceptability was >95%, and confirmed by using three different data sources (quantitative follow-up assessment, paradata from app intervention use, qualitative interview). The app intervention contained 4 modules (M1-M4) and a geo-locator sexual health resource finder. Although relationship partners individually used the app intervention (on their respective smartphones), questions and activities were built in each module to highlight within-couple comparisons and also encouraged couples to participate in discussion activities together. M1 was about enhancing communication and decision-making skills, while M2 focused on prevention strategies including creating a tailored prevention plan. M3 highlighted statistics of the HIV/STI epidemic, and M4 was about stigma and discrimination. Regarding promise, a two-fold increase was observed in the proportion of couples who created a tailored prevention plan when comparing baseline to follow-up assessment data, and while also considering their paradata. The next steps in this line of work would aim to improve the app intervention by integrating some of the acceptability feedback received, such as offering it in English and Spanish and adding content about importance of ART/PrEP adherence. Next steps also include, investigating - via mixed methods - how best to integrate the app intervention with local AIDS-service organizations (ASOs) and Community-based organizations (CBOs) for future scale up and improve use and adherence of evidence-based strategies among sexual minority men. Last but not least, a 4-month, Type 1 Hybrid Trial will be conducted to establish efficacy on couples' creation of a prevention plan, as well as participants' uptake of new evidence-based strategies (e.g., daily PrEP, regular testing, daily ART) and improving adherence of strategies currently in use. Findings from the Type 1 Hybrid Trial would inform best practices for integrating mHealth intervention science with brick-and-mortar services by including perspectives from the target population and ASOs/CBOs. The Type 1 Hybrid Trial study would occur in locations identified in Ending the HIV Epidemic Plan, such as Miami-Dade and Broward Counties in Florida.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 4-month randomized controlled trial with an informational control condition
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention Our PlanFrom baseline to 4-month post-test, participants in the intervention arm will have access to the Our Plan web app program. |
| Informational control | Other | Behavioral: Internation Informational ControlFrom baseline to 4-month post-test, participants in the informational control arm will not have access to the Our Plan web app program. Participants will instead receive a webpage with information about HIV/STI prevention options and resources to represent the current equivalent of a standard of care for online HIV resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-reported that currently self-identifies as a male
- self-reported in a sexual relationship with another self-identified male
- self-reported relationship length between 1 and 12 months
- self-reported anal sex with relationship partner in past month
- owns and uses an Internet-connected device (smartphone, tablet, computer)
Key exclusion criteria (1 listed)
- Does not meet one or more of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Our PlanFrom day 1 to day 120 (i.e., entire 4 month duration) of the trial, participants randomized to the intervention arm will be granted access and instructed to use the Our Plan program as directed. The Our Plan program includes modules covering topics of communication, decision-making, HIV/STI prevention, and stigma and discrimination. Each module contains content, questions, and activities for the participant and couple to complete. One goal of OurPlan is to help both partners of the couple create and use a risk- reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own confidence, intention, and perceived ability to use these strategies. | Behavioural | Intervention |
| Internation Informational ControlFrom day 1 to day 120 (i.e., entire 4 month duration) of the trial, participants randomized to the informational control condition will receive a webpage that contains information about HIV/STI prevention options and resources. This control condition represents the current equivalent of a standard of care for online HIV resources. | Behavioural | Informational control |
Primary outcome
Change in creation of a detailed risk-reduction plan by comparing baseline response to month 4 response
Time frame: Baseline, month 4
At both time points, participants will be asked if they created a detailed risk-reduction plan that contains evidence-based strategies with their partner. Dichotomous measure: yes/no
Change in number of evidence-based prevention strategies being used over time by comparing baseline response to month 4 response
Time frame: Baseline, month 4
Participants will be asked how many evidence-based HIV/STI prevention strategies they are currently using at both time points.
Change in confidence about using evidence-based prevention strategies over time by comparing baseline response to month 4 response
Time frame: Baseline, month 4
Participants will be asked about their perceived confidence in using evidence-based HIV/STI prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type scale response range of 1-5.
Change in intention to use evidence-based prevention strategies over time by comparing baseline response to month 4 response
Time frame: Baseline, month 4
Participants will be asked about their perceived intention to use evidence-based prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type scale response range of 1-5.
Change in self-efficacy to use evidence-based prevention strategies over time by comparing baseline response to month 4 response
Time frame: Baseline, month 4
Participants will be asked about their perceived ability to use evidence-based prevention strategies at both time points. Validated theoretical measure (single item) with Likert-type response range of 1-5.
2 secondary outcomes
Change in goal congruence on sexual health by comparing baseline response to month 4 response
Time frame: Baseline, month 4
Change in mutual constructive communication by comparing baseline response to month 4 response
Time frame: Baseline, month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Our Plan in people with HIV/AIDS, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in creation of a detailed risk-reduction plan by comparing baseline response to month 4 response (time frame: Baseline, month 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.